The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

NCT00911157 | Completed Phase 3 Results

• 1 other identifier: 111436
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 24

Brief Summary

The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.

Conditions

Thrombosis, Venous

Keywords

Pulmonary thromboembolism; contrast-enhanced MDCT; Deep Vein Thrombosis; Fondaparinux sodium

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)

  VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

  From Day 1 to Day 90 (±7 days)

Secondary Outcomes (4)

• Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)

  From Day 1 to Day 90 (±7 days)

• Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline

  Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)

• Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10

  Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)

• Percentage of Participants With a Bleeding Event

  Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).

Study Arms (2)

Fondaparinux

EXPERIMENTAL

Drug: Fondaparinux sodium

unfractionated heparin

OTHER

Drug: unfractionated heparin (UFH)

Interventions

Fondaparinux sodium DRUG

The dose of Fondaparinux will be determined based on a subject's body weight (\< 50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.

Also known as: GSK576428

Fondaparinux

unfractionated heparin (UFH) DRUG

UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.

unfractionated heparin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of acute proximal DVT based on contrast-enhanced Multi detector-row CT (MDCT) (not more than 10 days after the onset of the symptoms of DVT)
• Age:20 years
• Gender: No restriction
• Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period
• Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent

You may not qualify if:

• Symptomatic PE
• Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current DVT
• Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present
• Anticoagulant therapy for at least 24 hours to treat the current episode prior to entry into the study
• Active, clinically significant bleeding
• Thrombocytopenia (platelet count \<10×10⁴/µL at screening)
• Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension, or severe diabetes) or bleeding tendency
• Severe hepatic disorder
• Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
• Previous history of cerebral hemorrhage
• Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
• Previous history of Heparin-induced thrombocytopenia
• Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant)
• Severe renal disorder (serum creatinine \>2.0 mg/dL \[180 µmol/L\] at screening) in a well hydrated subject
• QT interval prolonged (QT interval corrected by Bazett's formula \[QTcB\] ≥450 msec; for patients with bundle branch block QTcB ≥480 msec) at screening

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

Aichi, 440-8510, Japan

Location

GSK Investigational Site

Fukuoka, 802-8555, Japan

Location

GSK Investigational Site

Gunma, 370-0829, Japan

Location

GSK Investigational Site

Gunma, 371-8511, Japan

Location

GSK Investigational Site

Hiroshima, 720-8520, Japan

Location

GSK Investigational Site

Hiroshima, 739-0651, Japan

Location

GSK Investigational Site

Hokkaido, 006-8555, Japan

Location

GSK Investigational Site

Hokkaido, 060-8543, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Hyōgo, 654-0155, Japan

Location

GSK Investigational Site

Ibaraki, 305-8576, Japan

Location

GSK Investigational Site

Ibaraki, 311-3193, Japan

Location

GSK Investigational Site

Kagoshima, 892-0853, Japan

Location

GSK Investigational Site

Kanagawa, 245-8575, Japan

Location

GSK Investigational Site

Kumamoto, 860-0008, Japan

Location

GSK Investigational Site

Kumamoto, 860-8556, Japan

Location

GSK Investigational Site

Mie, 514-8507, Japan

Location

GSK Investigational Site

Nagano, 399-0021, Japan

Location

GSK Investigational Site

Nagasaki, 859-3615, Japan

Location

GSK Investigational Site

Niigata, 951-8520, Japan

Location

GSK Investigational Site

Okayama, 701-1192, Japan

Location

GSK Investigational Site

Shizuoka, 430-8558, Japan

Location

GSK Investigational Site

Shizuoka, 438-8550, Japan

Location

GSK Investigational Site

Tokyo, 113-8655, Japan

Location

Related Publications (1)

• Nakamura M, Okano Y, Minamiguchi H, Munemasa M, Sonoda M, Yamada N, Hanzawa K, Aoyagi N, Tsujimoto H, Sarai N, Nakajima H, Kunieda T. Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients. Circ J. 2011;75(6):1424-32. doi: 10.1253/circj.cj-10-1036. Epub 2011 Apr 22.

  PMID: 21512258 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Fondaparinux; Heparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates; Glycosaminoglycans

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 1, 2009
• Study Start: June 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 23, 2016
• Results First Posted: June 10, 2010

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (24)